Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
- Conditions
- Atrial Flutter
- Registration Number
- NCT00213408
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 120
- first episode of symptomatic typical atrial flutter
- > 18 years old
- Prior antiarrhythmic drug treatment for atrial flutter
- History of cavotricuspid isthmus ablation
- Pregnancy
- Hyperthyroidism
- contraindication for anticoagulant therapy
- Life expectancy < 1 year
- contraindication to catheter ablation or to electrical cardioversion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Absence of typical atrial flutter recurrence at 6 and 12 months
- Secondary Outcome Measures
Name Time Method Cost/effectiveness ratio at 12 months
Trial Locations
- Locations (1)
CHU de Rouen
🇫🇷Rouen, Seine Maritime, France